Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
This study has been terminated.
(After utilizing all available recruitment resources, it was determined that the recruitment goal for the study could not be achieved)
Information provided by:
Massachusetts General Hospital
First received: September 8, 2006
Last updated: January 14, 2009
Last verified: January 2009
This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.
Generalized Anxiety Disorder
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder
Primary Outcome Measures:
- HAM-A rating scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CGI-S [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- CGI-I [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- LIFE-RIFT [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- MADRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- YMRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Q-LES-Q [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- QIDS-SR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- CD-RISC [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- ASI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- PSS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Life Experiences Survey [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- PSQI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2007 (Final data collection date for primary outcome measure)
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
Other Name: Geodon
Placebo Comparator: 2
Placebo administered daily for 8 weeks
This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are:
- Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder (GAD).
- Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on a lack of worsening of bipolar depression, mania or hypomania compared to placebo.
- Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female outpatients, aged 18 to 75 years.
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II).
- Current diagnosis of Generalized Anxiety Disorder (GAD).
- Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day).
- Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
- Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary.
- Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded.
- Patients with a history of alcohol or substance abuse or dependence within the last three months.
- Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded.
- Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder.
- History of hypersensitivity to or lack of response to ziprasidone.
- Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline.
- Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded.
- Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
- History of Neuroleptic Malignant Syndrome.
- Individuals with current clinically significant orthostatic hypotension are excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374543
|Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Naomi M. Simon, M.D.
||Massachusetts General Hospital
No publications provided
||Naomi Simon, Center for Anxiety and Traumatic Stress Disorders
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2006
||January 14, 2009
||United States: Institutional Review Board
Keywords provided by Massachusetts General Hospital:
Generalized Anxiety Disorder
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Affective Disorders, Psychotic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents